| Feb 27, 2026 | Drugs · Drug Quality Assurance | 13 cited references- 21 CFR 211.100(a). Absence of Written Procedures Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
- 21 CFR 211.160(b)(4). Written calibration procedures Written calibration procedures for instruments, apparatus, gauges, and recording devices are deficient in that they do not include specific directions, schedules, limits for accuracy and precision and provisions for remedial action if limits are not met.
- 21 CFR 211.42(c). Defined areas of adequate size for operations The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.
- 21 CFR 211.113(a). Procedures for non-sterile drug products Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established, written and followed.
- 21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
- 21 CFR 211.58. Buildings not maintained in good state of repair Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair.
- 21 CFR 211.165(f). Failing drug products not rejected Drug products failing to meet established standards, specifications and quality control criteria are not rejected.
- 21 CFR 211.84(d)(1). Identity Testing of Each Component The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.
- 21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling and drug products conform to appropriate standards of identity, strength, quality and purity.
- 21 CFR 211.194(a)(8). Identification of Person Performing Review of Lab Records Laboratory records are deficient in that they do not include the initials and signature of the second person reviewing the record for accuracy.
- 21 CFR 211.198(b)(2). Complaint Investigation/Follow-Up Findings Complaint records are deficient in that they do not include the findings of the investigation and follow-up.
- 21 CFR 211.170(b). Reserve samples identified, representative, stored Reserve drug product samples are not appropriately identified, representative of each lot or batch of drug product and retained and stored under conditions consistent with product labeling.
- 21 CFR 211.166(a). Lack of written stability program There is no written testing program designed to assess the stability characteristics of drug products.
| Official Action Indicated (OAI) |
| Dec 8, 2023 | Drugs · Drug Quality Assurance | 7 cited references- 21 CFR 211.165(f). Failing drug products not rejected Drug products failing to meet established standards, specifications and quality control criteria are not rejected.
- 21 CFR 211.84(d)(1). Identity Testing of Each Component The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.
- 21 CFR 211.100(a). Absence of Written Procedures Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
- 21 CFR 211.58. Buildings not maintained in good state of repair Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair.
- 21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling and drug products conform to appropriate standards of identity, strength, quality and purity.
- 21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
- 21 CFR 211.42(c). Defined areas of adequate size for operations The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.
| Official Action Indicated (OAI) |
| Oct 18, 2022 | Drugs · Drug Quality Assurance | 5 cited references- 21 CFR 211.84(d)(1). Identity Testing of Each Component The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.
- 21 CFR 211.165(f). Failing drug products not rejected Drug products failing to meet established specifications are not rejected.
- 21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
- 21 CFR 211.165(a). Testing and release for distribution Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release.
- 21 CFR 211.58. Buildings not maintained in good state of repair Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair.
| Official Action Indicated (OAI) |
| Oct 22, 2015 | Drugs · Drug Quality Assurance | None posted | Official Action Indicated (OAI) |
| Jul 2, 2013 | Drugs · Drug Quality Assurance | 6 cited references- 21 CFR 110.35(b)(2). Storage requirements Failure to properly store toxic cleaning compounds in a manner that protects against contamination of food.
- 21 CFR 110.80(b)(1). Teardown equipment/thorough cleaning Failure to take apart equipment as necessary to ensure thorough cleaning.
- 21 CFR 110.40(a). Precluding contaminants The design, construction, and use of equipment and utensils fails to preclude the adulteration of food with contaminants.
- 21 CFR 110.20(a)(1). Harborage areas Failure to properly store equipment and remove litter and waste that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures.
- 21 CFR 110.35(a). Cleaning and sanitizing operations Failure to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food and food-contact surfaces.
- 21 CFR 110.80(b)(2). Manufacturing conditions Failure to manufacture, package, and store foods under conditions and controls necessary to minimize contamination.
| Voluntary Action Indicated (VAI) |
| Sep 21, 2011 | Drugs · Drug Quality Assurance | 11 cited references- 21 CFR 110.37(e)(3). Hand drying Lack of a sanitary towel service or suitable hand drying devices.
- 21 CFR 110.35(a). Buildings/good repair Failure to maintain buildings, fixtures, and physical facilities in repair sufficient to prevent food from becoming adulterated.
- 21 CFR 110.80(b)(8). Metal / extraneous materials Failure to take effective measures to protect against the inclusion of extraneous material in food.
- 21 CFR 110.37(e)(5). Signs Lack of posted, readily understandable signs directing employees to wash and sanitize hands as appropriate.
- 21 CFR 110.20(b)(7). Screening Failure to provide adequate screening or other protection against pests.
- 21 CFR 110.37(a). Suitable temp. and pressure Failure to provide running water at a suitable temperature and under suitable pressure for cleaning of equipment, utensils and food-packaging materials and employee sanitary facilities.
- 21 CFR 110.20(b)(6). Fans/air blowing equipment Failure to locate and operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food.
- 21 CFR 110.80(b)(2). Manufacturing conditions Failure to manufacture, package, and store foods under conditions and controls necessary to minimize contamination.
- 21 CFR 110.20(b)(1). Sufficient space Failure to provide sufficient space for placement of equipment and storage of materials as necessary for the maintenance of sanitary operations and the production of safe food.
- 21 CFR 110.20(b)(5). Safety lighting and glass Failure to provide safety-type light bulbs and lighting fixtures suspended over exposed food.
- 21 CFR 110.35(d)(5). Shown to be effective The procedure used for cleaning and sanitizing of equipment and utensils has not been shown to provide adequate cleaning and sanitizing treatment.
| No Action Indicated (NAI) |
| Mar 31, 2010 | Drugs · Drug Quality Assurance | 12 cited references- 21 CFR 211.105(a). Identification of containers, lines, equipment All compounding and storage containers used during the production of a batch of drug product is not properly identified at all times to indicate contents.
- 21 CFR 211.100(a). Absence of Written Procedures There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
- 21 CFR 211.160(b)(3). Drug products-sampling procedures/specifications Laboratory controls do not include a determination of conformance to appropriate specifications for drug products.
- 21 CFR 211.165(b). Microbiological testing Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
- 21 CFR 211.68(a). Calibration/Inspection/Checking not done Routine calibration, inspection, and checking of mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
- 21 CFR 211.80(d). Status of Each Lot Identified Each lot of components, drug product containers, and closures was not appropriately identified as to its status in terms of being quarantined, approved or rejected.
- 21 CFR 211.80(a). Written Procedures Not Followed Written procedures are not followed for the identification, handling, sampling, testing, and approval of components, drug product containers, and closures.
- 21 CFR 211.67(c). Cleaning/maintenance records not kept Records are not kept for the maintenance, cleaning, sanitizing, and inspection of equipment.
- 21 CFR 211.198(a). Procedures to be written and followed Procedures describing the handling of all written and oral complaints regarding a drug product are not established.
- 21 CFR 211.137(a). Expiration date lacking Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
- 21 CFR 211.67(b). Written procedures not established/followed Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
- 21 CFR 211.22(a). Lack of quality control unit There is no quality control unit.
| Voluntary Action Indicated (VAI) |
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